Clinical Laserthermia Systems and Unio Health Partners in the US Announce Clinical Study
Lund, Sweden – Clinical Laserthermia Systems AB (publ) (“CLS” or “the Company”) today announced it has entered into an agreement with Unio Health Partners to conduct a Phase I clinical study titled “Micro Ultra-Sound Guided Focal Laser Ablation of Low to Intermediate Risk Prostate Cancer”.
The study recently received IRB approval from the FDA and will utilize CLS’s TRANBERG® Thermal Therapy System for image-guided focal laser ablation in conjunction with Exact Imaging’s ExactVu™ micro-ultrasound platform to visualize and target areas of interest in the prostate. The TRANBERG system will deliver targeted, precisely controlled focal laser ablation treatment at those areas while preserving the surrounding healthy tissue. The principal investigator for the study will be Paul E. Dato, MD, Director of Clinical Trials at Unio Health Partners.
In the US, over a million prostate biopsies are performed every year identifying more than 250,000 men with prostate cancer. These patients need minimally invasive therapies as alternatives to the standard treatments that often carry long term harmful side effects. CLS is actively recruiting and working with clinical and commercial partners to enable high precision, minimally invasive targeted fusion laser ablation of prostate cancer tumors to be performed under local anesthesia in an office setting or clinic as well as hospitals.
”Unio is excited to begin this feasibility study with CLS Americas for a new minimally invasive, office-based treatment for low-to-intermediate risk prostate cancer,” stated Franklin Gaylis, MD, FACS Executive Medical Director for Unio Health Partners. ”Our goal is to develop and refine new treatments we can later expand to our clinics and physicians that are not only effective in treating prostate cancer, but do so with low risk of infection and minimal side effects such as erectile dysfunction and urinary incontinence. An added potential benefit of this treatment approach is a reduction in the cost of localized prostate cancer care.”
”The ExactVu micro-ultrasound system is a new and exciting robust image guidance platform for urology offices and clinics,” stated Michael Magnani, president of CLS Americas. “Combined with our TRANBERG laser, urologists will be able to perform targeted, image-guided focal laser ablation treatments of prostate tissue, such as tumors, in an office or clinic. We look forward to collaborating with our study partner to maximize the potential workflow and patient benefits of our two systems.”
”This new feasibility study will be the first to combine micro-ultrasound platform for image guidance with focal laser ablation therapy to treat malignant prostate tumors,” said Paul E. Dato, MD, Director of Clinical Trials at Unio Health Partners. ”Our initial research indicates that the CLS TRANBERG laser and ExactVu micro-ultrasound system are two highly complementary systems with the potential to treat patients effectively with minimal unwanted side effects. The treatment’s transperineal access and workflow is very similar to the ExactVu-guided prostate biopsy process with a similar recovery time for the patient.”
About Exact Imaging
Exact Imaging (www.exactimaging.com) is the world’s leader in high-resolution micro-ultrasound systems enabling real-time imaging and guided biopsies in the urological market for prostate cancer. Exact Imaging’s ExactVu™ micro-ultrasound platform operates at 29 MHz and enables a whole new level of resolution with the benefits of ease of use, affordability, and is an extension of the current urological workflow.
About Unio Health Partners
Unio Health Partners (UHP), a differentiated Physician services platform, was founded in April 2021 with the partnership of Genesis Healthcare Partners (GHP). GHP’s best-in-class clinical program covers three sub-specialties (urology, gastroenterology, and radiation oncology) and offers numerous ancillary services, including pathology lab and pharmacy/in-office dispensing. With continued affiliations, UHP now provides services to 80 providers operating out of more than 50 locations in the greater San Diego, Los Angeles and Bay areas. UHP is led by a highly accomplished management team and provides a full suite of management services to its affiliated practices.
The information was submitted for publication, through the agency of the contact person set out below on April 25, 2023.
For more information, please contact:
Dan J. Mogren, CEO, Clinical Laserthermia Systems AB (publ)
Phone: +46 (0) 70-590 11 40
E-mail: dan.mogren@clinicallaser.com
About CLS
Clinical Laserthermia Systems AB (publ) develops and sells the TRANBERG® Thermal Therapy Systems, including Thermoguide Workstation and sterile disposables, for minimally invasive treatment of cancer tumors and drug-resistant epilepsy, according to regulatory approvals in the EU and the US. The products are marketed for image-guided laser ablation and used in studies for treatment with imILT®, the Company's interstitial laser thermotherapy for immunostimulatory ablation with potential abscopal effects. CLS is headquartered in Lund and has subsidiaries in Germany, the US and Singapore. CLS is listed on the Nasdaq First North Growth Market under the symbol CLS B. The Certified Advisor (CA) is FNCA Sweden AB, Tel: +46 8 528 00 399. E-mail: info@fnca.se.
For more information about CLS, please visit the Company's website: clinicallaser.se